- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02382133
Comparison of Nasal and Forehead Oximetry in Critically Ill Patients at Risk for Decreased Peripheral Perfusion
8. maj 2017 opdateret af: Lynn Schallom, Washington University School of Medicine
Continuous pulse oximetry monitoring is the standard of care in critically ill patients in emergency departments, operating rooms and intensive care units.
In patients with poor peripheral perfusion (low blood flow) due to peripheral vascular disease, low body temperature, or shock and the use of medications to raise the blood pressure, clinicians have difficulty obtaining an accurate measurement.
This study compares the accuracy of forehead oximetry sensors to nasal alar sensors to lab oximetry measures and on the rate of device related pressure ulcers with both.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Continuous pulse oximetry monitoring is the standard of care in critically ill patients in emergency departments, operating rooms and intensive care units.
In patients with poor peripheral perfusion (low blood flow) due to peripheral vascular disease, low body temperature, or shock and the use of medications to raise the blood pressure, clinicians have difficulty obtaining an accurate measurement.
Several studies have demonstrated the utility of forehead sensor measurements under these clinical conditions.
Forehead sensor measurement is considered to be a more central measurement than with digit or ear sensors.
However the sensor requires a head band for accurate measurement.
On a regular basis, the forehead sensor has led to pressure ulcer development at Barnes-Jewish Hospital despite following vendor recommendations for alternating placement every 8 hours from one side of the forehead to the other.
An alternate sensor placed on the nose has recently demonstrated rapid detection of induced drops in oxygen saturation.
It has also demonstrated correlation with arterial oxygen saturation measured in a clinical laboratory.
The oxygen saturation measurement from the nose is also considered a central measurement.
However, studies of the nose sensor were conducted in healthy subjects or during anesthesia care over several hours.
Therefore, research is needed to examine the accuracy of the nose sensor in the ICU patient population.
In addition, due to concerns for sensor related pressure ulcers in patients with decreased perfusion, the sensor needs to be evaluated for extended periods of time.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
43
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Missouri
-
Saint Louis, Missouri, Forenede Stater, 63110
- Barnes-Jewish Hospital at Washington University
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 90 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
1. Presence of an existing arterial catheter for blood sampling and one of the following:
- Difficulty obtaining a consistent signal from a digit or ear sensor or
- On pressors of at least 0 .10 mcg/kg/min of norepinephrine or
- Core temperature < or equal to 35 degrees C
Exclusion Criteria:
- Anatomic impediments (burns, wounds, dressings, etc.) to placement of the sensor on the forehead or nasal alar
- History of known dyshemoglobinemias evidenced by carboxyhemoglobin levels > 10% or methemoglobin level > 2%
- Severe anemia with hemoglobin < 5 g/dL
- Pregnant women
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Nasal alar oxygen sensor
Application of a nasal alar oxygen sensor
|
Application of a nasal alar oxygen sensor
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Accuracy as Indicated by Co-oximetry Measure of Arterial Oxygen Saturation
Tidsramme: 24 hours
|
accuracy of sensor measure was defined as sensor measurements within 3% of co-oximetry measures
|
24 hours
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Device Related Pressure Ulcer
Tidsramme: 5 days
|
assessment for development of pressure ulcer at forehead sensor, "OxiMaxTM, Nellcor,Covidien" and nasal alar sensor, "Alar One-SenseTM, Xhale Assurance"
|
5 days
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Marilyn E Schallom, RN, PhD, Barnes-Jewish Hospital at Washington University
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2014
Primær færdiggørelse (Faktiske)
1. juli 2016
Studieafslutning (Faktiske)
1. september 2016
Datoer for studieregistrering
Først indsendt
10. februar 2015
Først indsendt, der opfyldte QC-kriterier
5. marts 2015
Først opslået (Skøn)
6. marts 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. juni 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. maj 2017
Sidst verificeret
1. maj 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 201408123
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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